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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00570063 |
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Date of registration:
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06/12/2007 |
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Primary sponsor: |
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Public title:
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Double Blind, Randomized, 3 Week Inpatient Study To Evaluate The Safety & Efficacy Of PF-02545920 Compared With Placebo
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Scientific title:
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A Phase 2, Multicenter, Double Blind, Randomized, Fixed Dose, Parallel Group, 3 Week Inpatient Treatment Study To Evaluate The Safety, Efficacy And Pharmacokinetics Of PF-02545920 Compared With Placebo In The Treatment Of Acute Exacerbation Of Schizophrenia |
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Date of first enrolment:
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November 2007 |
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Target sample size:
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35 |
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Recruitment status: |
Terminated |
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URL:
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http://clinicaltrials.gov/show/NCT00570063 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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Pfizer CT.gov Call Center |
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Address:
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Telephone:
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Email:
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Affiliation:
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Pfizer |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Have a current diagnosis of schizophrenia.
2. Increase in symptoms over the past 2-4 weeks.
3. Willing to remain inpatients for the duration of the trial.
Exclusion Criteria:
1. Evidence or history of clinically significant medical problems.
2. Females of childbearing potential.
3. A primary psychiatric diagnosis other than schizophrenia.
4. A diagnosis of substance abuse or dependence in the last 6 months.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Schizophrenia
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Intervention(s)
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Drug: PF-02545920
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Drug: Placebo
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Primary Outcome(s)
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Change from baseline to endpoint on the Positive and Negative Symptom Assessment Scale (PANSS).
[Time Frame: 3 weeks]
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ECG and ESRS-A as safety measures of change from baseline to endpoint
[Time Frame: 3 weeks]
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Secondary Outcome(s)
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Change from baseline to endpoint on the PANSS subscales (positive, negative and general psychopathology
[Time Frame: 3 weeks]
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Changes on the Clinical global impression scales (Severity and Improvement)
[Time Frame: 3 weeks]
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Pharmacokinetic parameters (how the body handles the drug)
[Time Frame: 3 weeks]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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